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Clinical Trial Details

Trial ID: L6927
Source ID: NCT04854083
Associated Drug: Semaglutide, 1.34 Mg/Ml
Title: Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes
Acronym: MitoSema
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type2 Diabetes
Interventions: DRUG: Semaglutide, 1.34 mg/mL|DRUG: Placebo
Outcome Measures: Primary: HbA1c, Change in HbA1c (%), from baseline to 12 months | Secondary: HbA1c, Change in HbA1c (%), from baseline to 6 months|Fasting plasma glucose, Change in fasting plasma glucose (mmol/l), from baseline to 6 and 12 months|Body weight, Change in body weight (kg), from baseline to 6 and 12 months|Percentage of patients reaching ≥5%,10% & 15% weight loss, from baseline to 6 and 12 months|Waist circumference, Change in waist circumference (cm), from baseline to 6 and 12 months|Change in appetite and eating habits, control of eating, Using questionnaire Control of Eating (CoEQ), from baseline to 6 and 12 months|Change in appetite and eating habits, binge eating, Using questionnaires Binge Eating Scale(BES), Questionnaire on Eating and Weight Patterns (QEWP), from baseline to 6 and 12 months|Change in appetite and eating habits, emotional, external and restraint eating, Using questionnaire Dutch Eating Behaviour Questionnaire (DEBQ), from baseline to 6 and 12 months|Blood pressure, Change in blood pressure (mmHg), from baseline to 6 and 12 months|Plasma lipids, Change in lipids (total cholesterol, LDL, HDL, TAG) (mmol/l), from baseline to 6 and 12 months|Changes in concomitant antidiabetic medications, Change in number of antidiabetic medications, from baseline to 6 and 12 months|Changes in concomitant antihypertensive medications, Change in number of antihypertensive medications, from baseline to 6 and 12 months|Changes in concomitant lipid medications, Change in number of lipid medications, from baseline to 6 and 12 months|Mitochondrial DNA quantification, Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in adipose tissue and skeletal muscle, from baseline to 6 and 12 months|Change in the transcriptomics profile of adipose tissue and skeletal muscle, Change in the transcriptomics profile by qPCR and/or RNA sequencing, from baseline to 6 and 12 months|Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver, Change in the oxygen uptake and perfusion measured by PET/CT (in vivo), from baseline to 12 months
Sponsor/Collaborators: Sponsor: Kirsi Pietiläinen | Collaborators: University of Helsinki|Turku University Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-17
Completion Date: 2025-08
Results First Posted:
Last Update Posted: 2022-03-31
Locations: University of Helsinki, Helsinki, Finland
URL: https://clinicaltrials.gov/show/NCT04854083